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Northera NDA Resubmitted By Chelsea - Analyst Blog

Chelsea Therapeutics International Ltd.
(
CHTP
) recently resubmitted a new drug application (NDA) to the US
Food and Drug Administration (FDA) for Northera (droxidopa). The
company is looking to get Northera approved for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH) in patients
with primary autonomic failure (Parkinson's disease, multiple
system atrophy and pure autonomic failure), dopamine beta
hydroxylase deficiency and non-diabetic autonomic neuropathy.

Results from 306 B, a large phase III study demonstrating
improvement in dizziness / lightheadness, the main symptom of NOH
and confirming findings from the previous 301 study, was included
in the resubmitted NDA.

Chelsea Therapeutics had initially submitted an NDA for
Northera in Sep 2011. However, the company received a complete
response letter (CRL) in Mar 2012. In the CRL, the FDA
recommended that Chelsea Therapeutics should conduct and submit
data from an additional positive study supporting efficacy in the
301 study. The company was also asked to design a study which
would demonstrate durability of effect over a 2- to 3-month
period.

In the CRL, FDA also mentioned an additional bioequivalence
study for the approval of Northera 300 mg capsules. Chelsea
Therapeutics was considering making these capsules commercially
available to complement the 100 mg and 200 mg capsules which were
being utilized in the clinical program by Chelsea
Therapeutics.

Taking note of this, Chelsea Therapeutics included a
bioequivalence study for the 300 mg dose in the resubmitted
NDA.

The resubmitted NDA will most likely come up for review before
the FDA's Cardiovascular and Renal Drug Advisory Committee
(CRDAC). There is also a possibility raised by the FDA about
Northera gaining accelerated approval and hinted that short-term
clinical benefit would be considered adequate replacements to
predict long-term clinical benefits under the accelerated
approval.

Northera was granted orphan drug designation in 2007 and
received fast track designation.

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